Yesterday, 25 April 2018, AG Wathelet has handed down his opinion in the Teva v Gilead reference (Case C-121/17) suggesting that the question should be answered as follows:

“The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent … A product is protected by a patent … if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.” (emphasis added).

This case concerned an SPC Gilead had obtained for the combination of tenofovir and emtricitabine based upon Gilead’s patent, which claimed “A pharmaceutical composition comprising a compound according to any one of claims 1 to 25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”. It was clear that the patent protected tenofovir, which was claimed in claim 25, but emtricitabine was not disclosed in the patent and there was no evidence that it was known to be efficacious at the priority date of the patent. Gilead had relied upon the fact that “optionally other therapeutic ingredients” would encompass emtricitabine to obtain the SPC.

The AG agreed with Arnold J, who made the reference, that it is necessary but not sufficient that the product falls within at least one of the claims of the basic patent under the Extent of Protection Rules**. However he did not agree with Arnold J that it is necessary to determine whether the product embodies the inventive advance of the patent, which is referred to in the CJEU’s decision in Actavis v Sanofi (C-443/12), noting that the Actavis case was only concerned with Article 3(c), not 3(a) and commenting that he had difficulty in understanding the difference between the “core inventive advance” and the invention disclosed by the claims. Instead he found it clear from CJEU case law that the only means for determining whether the product is protected by the basic patent “is to be found only in the wording, or interpretation of the wording, of the claims of the patent … and nowhere else”. The issue is with what degree of specificity or abstraction a product needs to be “specified” in the claims.

It is clear that the AG is of the opinion that the patent did not “specifically and precisely” identify emtricitabine for the purposes of Article 3(a) although, as the AG acknowledges, this is a matter for the national court to decide. What is not clear is the extent (if any) to which the AG had in mind the two other pending references***: Royalty Pharma’s application (C-650/17), which concerns an SPC for sitagliptin based upon a patent which did not individually disclose sitagliptin (indeed sitagliptin was developed after the priority date of the patent) and Sandoz v GD Searle ([2018] EWCA Civ 49) which concerns an SPC for darunavir based upon a patent which did not individually disclose darunavir but had claims in the form of a Markush formula, which covered darunavir.

The AG for the first time, suggests that the CJEU should take account of what would have been obvious to a person skilled in the art as having been identifiable in the claims of the patent at the priority date. It is difficult to see how such a test would be a simple test that can be easily applied by national patent offices without, in some cases, needing evidence as to what the skilled person would have known at the priority date. It will be interesting to see if the CJEU follows this opinion.

*Regulation No 469/2009
**As set out in Article 69 of the European Patent Convention
***The AG refers to the existence of the two other references at the start of the opinion, but they are not referred to expressly anywhere else.

2 comments

I confess not knowing much about SPC, and if some statements are blatantly wrong, just ignore them.

I am fully aware that the present case is about a SPC and not a patent. Some parallels with the famous “pemetrexed” (Actavis vs. Lilly) case are however difficult to ignore.

According to AG Wathelet, “a product is protected by a patent … if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent”. I can only support this point of view.

A question would be: are equivalents also concerned in case of a SPC? If the answer is positive, then the SPC can cover equivalents, which however does not please me, but I might be wrong. If an SPC does not cover equivalents, then I am challenging Lord Neuberger’s decision.

Actually, whatever the reply to this question might be, in view of the position of AG Wathelet, Lord Neuberger would not have been able to come up with his new equivalent theory, and he should have refrained to blame the examiner to limit the claim to sodium salts, as in view of the Guidelines and the case law of the BA, the examiner had no choice.

At the priority date, Lilly had never dreamed about anything than pemetrexed disodium. What was said in the introductory part of the description was pure speculation, and the examiner should have insisted that this speculative part should have been deleted.

I do not want to reopen the discussion on Actavis vs. Lilly, but if feel some rumbling inside me.

Was it obvious at the priority date that any other salt than pemetrexed disodium was specifically and precisely identifiable in the wording of the claims of the basic patent? In spite of a famous judgement, I still have strong doubts.

It is clear that the matters are different, equivalents on the one side and SPC on the other, but it is difficult to deny some links.